Study summary

The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

Additional Study Details

Phase
4
Product
  • Tacrolimus granules
  • Tacrolimus capsules
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    47
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Scientific Results Summary 2
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A paediatric, open, follow up study with Modigraf examining safety and efficacy in de novo allograft recipients? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

      Contact Us
      Contact Us
      Completed
      Site FR60 Groupement Hospitalier EST
      Bron, France, 69677
      Completed
      Site ES23 Hospital Universitario La Paz
      Madrid, Spain, 28046
      Completed
      Site ES20 Hospital Universitario La Paz
      Madrid, Spain, 28046
      Completed
      Site FR61 Hopital Robert Debre
      Paris Cedex 19, France, 75945
      Withdrawn
      Site GB11 Great Ormond Street Hospital
      London, United Kingdom, WC1N3JH
      Completed
      Site GB14 Alder Hey Children Hospital
      Liverpool, United Kingdom, L12 2AP
      Completed
      Site ES22 H.U. Gregorio Maranon
      Madrid, Spain, 28007
      Withdrawn
      Site BE41 U.Z. Leuven
      Leuven, Belgium, 3000
      Completed
      Site DE30 Universitätsklin Heidelberg
      Heidelberg, Germany, 69120
      Completed
      Site ES21 Hospital Universitario La Paz
      Madrid, Spain, 28046
      Completed
      Site BE40 Clinique Univ. Saint Luc
      Brussels, Belgium, 1200
      Completed
      Site GB13 Cent. Manchester Uni. Hospital
      Manchester, United Kingdom, M13 9WL
      Completed
      Site DE31 Kliniken der Medizinischen Hoc
      Hannover, Germany, 30625
      Withdrawn
      Site GB10 Birmingham Children's Hospital
      Birmingham, United Kingdom, B4 6NH
      Completed
      Site PL50 Centrum Zdrowia Dziecka
      Warsaw, Poland, 04-730

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

      Will I have to stop my current treatment to participate in a clinical trial?

      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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